On September 16, 2024 Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immune-oncology therapeutics based on its proprietary ADAPTIR and ADAPTIR-FLEX platform technologies, reported that it has entered into securities purchase agreements with certain healthcare-focused and institutional investors to purchase (i) 9,090,910 shares of its common stock or pre-funded warrants in lieu thereof and (ii) warrants to purchase up to an aggregate of 18,181,820 shares of its common stock (the "Common Warrants") at a purchase price of $0.33 per share and associated Common Warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Aptevo Therapeutics, SEP 16, 2024, View Source [SID1234646668]). Each share of common stock is being offered together with two Common Warrants, each to purchase one share of common stock. The Common Warrants will have an exercise price of $0.33 per share, are exercisable upon stockholder approval, and will expire five years following the date stockholder approval.

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The offering is expected to close on or about September 18, 2024, subject to customary closing conditions. Roth Capital Partners is acting as placement agent of the offering. Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $3.0 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, and other general corporate purposes.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-281892), that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on September 16, 2024. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected]. This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company also has agreed to amend certain existing warrants that were previously issued in July 2024, April 2024 and November 2023 to purchase up to 11,822,774 shares of the Company’s common stock and have exercise price of $0.515 per share, effective upon the closing of the offering, such existing warrants will have a reduced exercise price of $0.33 per share and shall become exercisable upon stockholder approval.

On September 16, 2024 Astrazeneca reported results from the HIMALAYA Phase III trial that showed Imfinzi (durvalumab) plus Imjudo (tremelimumab) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment (Press release, AstraZeneca, SEP 16, 2024, View Source [SID1234646667]).

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These results from HIMALAYA will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024 in Barcelona, Spain (presentation 947MO).

At five years of follow-up, this latest exploratory analysis showed that a single priming dose of Imjudo added to Imfinzi, called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI] 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% of those treated with sorafenib.

In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib.

Lorenza Rimassa, MD, Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy and a lead investigator in the HIMALAYA trial, said: "Treatment with durvalumab plus tremelimumab for patients with advanced liver cancer doubled the overall survival rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. These data reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease."

Sarah Manes, Liver Cancers Program Director at Global Liver Institute, said: "Reaching the five-year survival milestone is both clinically significant and emotionally meaningful for people with advanced liver cancer and their families. We are thrilled to see this progress in improving outcomes with new treatment options, bringing new hope for long-term survivorship to patients in our community."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "It is remarkable to see nearly 20 per cent of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about seven per cent of patients living that long historically. This is a major step forward, setting a new survival benchmark. This underscores our commitment to following patients for the long term to help us better characterise the enduring clinical benefits of this innovative priming approach with an anti-CTLA-4 antibody added to PD-L1 blockade."
Summary of updated survival results: HIMALAYA

OSi, ii

​STRIDE
(n=393)

Sorafenib
(n=389)

​Median duration of follow-up, in months (95% CI)

​62.5 (59.5-64.8)

59.9 (58.3-61.5)

​OS HR (95% CI)

0.76 (0.65-0.89)

p-value (2-sided)iii

0.0008

​OS rateiv at 60 months (95% CI), %

19.6

9.4

DC at 60 months

Number of patients

OS rate, %

43

28.7

17

12.7

DpRv >75% at 60 months

Number of patients

OS rateiv, %

27

72.7

3

33.3

DpRv >50%–≤75% at 60 months

Number of patients

OS rateiv, %

34

57.8

12

32.1

i. Updated analysis data cut-off: 01 March 2024, with 82% OS data maturity
ii. OS HRs and 95% CIs were calculated using a Cox proportional hazards model adjusting for treatment, aetiology, ECOG performance status, and macrovascular invasion
iii. Nominal p-value
iv. OS rates at 60 months were estimated using Kaplan-Meier methodv. DpR represents the percentage of tumor shrinkage from baseline observed at the time of best objective response evaluation
The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, and no new safety signals were observed with longer follow-up. Serious treatment-related adverse events, defined as Grade 3 or 4 and including death, were experienced by 17.5% of patients treated with the STRIDE regimen versus 9.9% of patients treated with sorafenib, with no new events occurring after the primary analysis for STRIDE.

Imfinzi in combination with Imjudo is approved for the treatment of adults with advanced or unresectable HCC in the US, EU (in the 1st-line setting), Japan and several other countries. Imfinzi monotherapy is also approved in Japan in this setting.

Notes

Liver cancer
Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death, with nearly 900,000 people worldwide diagnosed each year and a high prevalence in certain regions of Asia.1-2 An estimated 80-90% of all patients with HCC also have cirrhosis. Chronic liver diseases such as cirrhosis are associated with inflammation that over time can lead to the development of HCC.3

Advanced-stage HCC prognosis is poor, with a five-year survival rate of only 7%.4 More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.5 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the power of the immune system to treat HCC.5

HIMALAYA
HIMALAYA is a randomised, open-label, multi-centre, global Phase III trial of Imfinzi monotherapy and a regimen comprising a single priming dose of Imjudo 300mg added to Imfinzi 1500mg followed by Imfinzi every four weeks (STRIDE regimen) versus sorafenib, a standard-of-care multi-kinase inhibitor.

The trial included a total of 1,324 randomised patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localised to the liver and surrounding tissue).

The trial was conducted in 181 centres across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint was OS for the combination versus sorafenib and key secondary endpoints included OS for Imfinzi versus sorafenib, objective response rate and progression-free survival (PFS) for the combination and for Imfinzi alone.

Imfinzi
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with Imjudo (tremelimumab) in unresectable HCC. Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in combination with chemotherapy (carboplatin plus paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient in the US.

In addition to its indications in gastrointestinal (GI) cancers, Imfinzi is the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy. Imfinzi is also approved for the treatment of extensive-stage small cell lung cancer (SCLC) and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. In limited-stage SCLC, Imfinzi demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of OS and PFS compared to placebo in patients who had not progressed following standard-of-care concurrent chemoradiotherapy in the ADRIATIC Phase III trial.

Imfinzi in combination with neoadjuvant platinum-containing chemotherapy before surgery and as adjuvant monotherapy after surgery has been approved for patients in the US and several other countries for the treatment of adult patients with resectable NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.

Imfinzi plus chemotherapy followed by Imfinzi alone was recently approved in the US for mismatch repair deficient patients with primary advanced or recurrent endometrial cancer. This regimen was also approved in the EU, in addition to Imfinzi plus chemotherapy followed by Imfinzi and Lynparza (olaparib) for mismatch repair proficient patients.

In muscle-invasive bladder cancer, Imfinzi in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of OS versus neoadjuvant chemotherapy in the NIAGARA Phase III trial.

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several GI and gynaecologic cancers and other solid tumours.

Imjudo
Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, Imjudo is being tested in combination with Imfinzi across multiple tumour types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).

On September 16, 2024 Novartis reported an updated analysis from the pivotal Phase III NATALEE trial, investigational Kisqali (ribociclib) added to endocrine therapy (ET) shows a deepening benefit beyond the three-year treatment period, reducing the risk of recurrence by 28.5% (HR=0.715; 95% CI 0.609–0.840; P<0.0001), compared to ET alone, in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) (Press release, Novartis, SEP 16, 2024, View Source [SID1234646666]). This invasive disease-free survival (iDFS) benefit was also consistent across all pre-specified patient subgroups, including those with node-negative disease1. Late-breaking data from this four-year post-hoc analysis will be presented today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024.

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iDFS benefit across pre-specified subgroups1:

Subgroup 4-year iDFS rate, % 4-year iDFS absolute benefit, %
Intention-To-Treat Population Kisqali + ET: 88.5
ET alone: 83.6
(HR=0.715; 95% CI 0.609–0.840) 4.9
AJCC Tumor Stage II Kisqali + ET: 93.9
ET alone: 89.6
(HR=0.644; 95% CI 0.468–0.887) 4.3
AJCC Tumor Stage III Kisqali + ET: 84.3
ET alone: 78.4
(HR=0.737; 95% CI 0.611–0.888) 5.9
Node-negative disease Kisqali + ET: 92.1
ET alone: 87.0
(HR=0.666; 95% CI 0.397–1.118) 5.1
Results were also consistent across secondary efficacy endpoints, including distant disease-free survival (HR=0.715; 95% CI 0.604–0.847; P<0.0001), with a trend for improvement in overall survival (HR=0.827; 95% CI 0.636–1.074; one-sided P value=0.0766)*1.

"Clinicians are eager to address the substantial risk of cancer coming back as metastatic disease for patients diagnosed with HR+/HER2- early-stage breast cancer," said Peter A. Fasching, M.D., Professor of Translational Medicine, University Hospital Erlangen and Comprehensive Cancer Center Erlangen-EMN and NATALEE trial investigator. "With longer follow-up, the clinically relevant benefit of adding ribociclib to endocrine therapy continues to improve, even after the end of ribociclib treatment, for both node-positive and node-negative patients. This is important because NATALEE includes a broad population of patients at risk of recurrence, including those diagnosed with high-risk, node-negative disease who deserve access to new treatment options to reduce that risk."

Safety remains consistent with previously reported results with no new safety signals identified1. Adverse events (AEs) of special interest (grade 3 or higher) were neutropenia (44.4%), liver-related AEs (e.g., elevated transaminases) (8.6%), and QT interval prolongation (1.0%)1.

"As we anticipate regulatory action from health authorities worldwide, we are highly encouraged by these longer-term results from NATALEE showing a deepening efficacy benefit for Kisqali," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "A large number of people diagnosed with HR+/HER2- early breast cancer remain at risk of recurrence, and these results add to the growing body of evidence supporting the potential of Kisqali to reduce this risk consistently across a broad population, including patients with node-negative disease who have few options beyond ET."

Novartis submitted NATALEE data to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in 2023, and FDA regulatory action is expected in Q3.

*Results based on overall survival analysis at time of 4-year post-hoc analysis; additional follow-up is planned to obtain more mature OS data.

About NATALEE
NATALEE is a global Phase III multi-center, randomized, open-label trial to evaluate the efficacy and safety of Kisqali (ribociclib) with ET as an investigational adjuvant treatment versus ET alone in patients with stage II and III HR+/HER2- EBC, being conducted in collaboration with TRIO4,5. The adjuvant ET in both treatment arms was a non-steroidal aromatase inhibitor (NSAI; anastrozole or letrozole) and goserelin if applicable4,5. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) as defined by the Standardized Definitions for Efficacy End Points (STEEP) criteria4,5. A total of 5,101 adult patients with HR+/HER2- EBC across 20 countries were randomized in the trial4,5.

About Kisqali (ribociclib)
Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Regulatory reviews for Kisqali as an EBC treatment are ongoing worldwide, including in the U.S., EU and China.

Kisqali has been approved as a treatment for metastatic breast cancer (MBC) patients in 99 countries worldwide, including by the U.S. FDA and the European Commission6,7. In the U.S., Kisqali is indicated for the treatment of adults with HR+/HER2- advanced or MBC in combination with an AI as initial ET or fulvestrant as initial ET or following disease progression on ET in post-menopausal women or in men6. In the EU, Kisqali is approved for the treatment of women with HR+/HER2- advanced or MBC in combination with either an AI or fulvestrant as initial ET or following disease progression7. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist6,7.

In MBC, Kisqali has consistently demonstrated statistically significant overall survival benefit across three Phase III trials8-18. The NCCN Guidelines for breast cancer recommend ribociclib (Kisqali) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment of people living with HR+/HER2- when combined with an AI, making Kisqali the preferred first-line treatment of choice for US prescribers in HR+/HER2- MBC19. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line pre-menopausal patients with HR+/HER2- advanced breast cancer20. Further, Kisqali in combination with either letrozole or fulvestrant has uniquely, among other CDK4/6 inhibitors, received a score of four out of five for post-menopausal patients with HR+/HER2- advanced breast cancer treated in the first line21.

Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com

On September 16, 2024 ScaleReady and Bio-Techne Corporation (NASDAQ: TECH) reported the launch of the G-Rex optimized ProPakTM GMP Cytokines, ideally tailored to high efficiency closed system cell and gene-modified cell therapy (CGT) manufacturing (Press release, Bio-Techne, SEP 16, 2024, View Source [SID1234646664]).

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The ProPakTM GMP Cytokine product consists of a weldable bag filled with liquid formulated GMP-grade cytokines, specifically interleukin-7 (IL-7) or interleukin-15 (IL-15), commonly used in the ex vivo manufacturing of CAR-T and TCR-T cells. The quantity of IL-7 and IL-15 contained in each ProPakTM is sufficient to dose a one (1) liter G-Rex bioreactor at the recommended 10ng/mL concentration. The use of ProPak GMP cytokines will enable manufacturers of CAR-T and TCR-T cell therapies to reduce operating costs and complexity by dramatically simplifying the process of acquiring, storing, preparing, and administering these critical reagents for use in cGMP manufacturing.

"Bio-Techne is deeply committed to highly efficient manufacture of lifesaving cell and gene-modified cell therapies," said Will Geist, President (Protein Sciences) at Bio-Techne Corporation. "ProPakTM GMP Cytokines were optimized for use with the leading G-Rex platform by providing the precise quantity of cytokines needed for highly simplified closed system expansion of CAR-T and TCR-T cell drug products with excellent cell characteristics."

"The G-Rex optimized ProPakTM GMP Cytokine is a differentiated product as it is uniquely designed to enable users of G-Rex to manufacture CAR-T and TCR-T drug products with far more simplicity than is possible with any other cytokine vendor," said Josh Ludwig, Global Commercial Director at ScaleReady. "It eliminates the need for cytokine reconstitution and all of the related headaches in favor of a hands-off ballroom style G-Rex manufacturing approach.

"With the incredible response to our G-Rex Grant Program moving G-Rex into the majority of CGT clinical trials, the G-Rex optimized ProPak is the perfect next step in G-Rex manufacturing simplicity. Grant applicant or not, we will help every G-Rex user cost effectively perform comparability studies to integrate the ProPak GMP Cytokines," concluded Josh Ludwig.

Parties interested in learning more and/or evaluating the ProPakTM GMP Cytokines can reach out to [email protected].

On September 16, 2024 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 18/535,108 entitled "Material and Method for Treating Cancer (Press release, UroGen Pharma, SEP 16, 2024, View Source [SID1234646663])."

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The allowed claims relate to the combination of UroGen’s RTGel technology with medac’s licensed proprietary lyophilized mitomycin formulation and cover the use of UroGen’s UGN-103 and UGN-104 development programs in the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) and low-grade upper tract urothelial cancer (LG-UTUC), respectively. The U.S. patent, once issued, will have an expiration date in December 2041.

"Allowance of this patent application strengthens our intellectual property position for our next-generation investigational programs for patients with urothelial cancers," said Liz Barrett, President and CEO of UroGen. "We believe that the combination of UroGen’s RTGel technology with medac’s patent-protected lyophilized mitomycin has the potential to provide advantages related to production, cost, supply, and product convenience for patients. Our vision remains to develop innovative medicines that advance the care of patients, and this patent allowance is a key element of our strategy to build a long-term growth company."

In January 2024, UroGen entered into a licensing and supply agreement with medac to develop UGN-103 for LG-IR-NMIBC and UGN-104 for LG-UTUC. In April 2024, the FDA accepted UroGen’s IND application for UGN-103 and the company is currently onboarding clinical sites for the study. The company anticipates commencing a similar study for UGN-104, which is expected in early 2025.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. UroGen completed the NDA submission for UGN-102 in August 2024, ahead of schedule. UroGen anticipates potential FDA approval in early 2025 if the NDA is accepted for filing by the FDA and priority review is granted.

About UGN-103 and UGN-104

UGN-103 and UGN-104 are innovative mitomycin formulations in development by UroGen for the treatment of LG-IR-NMIBC and LG-UTUC, respectively. UGN-103 aims to streamline manufacturing and reconstitution processes while providing intellectual property coverage until December 2041; it utilizes UroGen’s RTGel technology for prolonged mitomycin exposure. UGN-104, also leveraging RTGel technology, is designed for treating low-grade upper tract urothelial cancer and is anticipated to enter Phase 3 trials in early 2025, offering a non-surgical treatment option with similar intellectual property protection.